510(k) Report

FDA applicant

Gfe Medizintechnik GmbH

Salt Lake City, UT1 decision2003–20030 recalls

FDA records 1 decision for Gfe Medizintechnik GmbH (Salt Lake City, UT) in 2003: 1 510(k) clearance. All are in product code FTL (Mesh, Surgical, Polymeric). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Gfe Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gfe Medizintechnik GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gfe Medizintechnik GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FTLMesh, Surgical, Polymeric1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031225Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Gfe Medizintechnik GmbH · 20033cite it

What has FDA decided for it lately?

  • K031225Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Gfe Medizintechnik GmbH · 2003

The one decision as Gfe Medizintechnik GmbH →